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EP1879637B1 - Corps pour catheter ou gaine - Google Patents

Corps pour catheter ou gaine Download PDF

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Publication number
EP1879637B1
EP1879637B1 EP20060751861 EP06751861A EP1879637B1 EP 1879637 B1 EP1879637 B1 EP 1879637B1 EP 20060751861 EP20060751861 EP 20060751861 EP 06751861 A EP06751861 A EP 06751861A EP 1879637 B1 EP1879637 B1 EP 1879637B1
Authority
EP
European Patent Office
Prior art keywords
strip
polymeric material
segment
wall
strips
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP20060751861
Other languages
German (de)
English (en)
Other versions
EP1879637A2 (fr
EP1879637A4 (fr
Inventor
Xiaoping Guo
Richard E. Stehr
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical Atrial Fibrillation Division Inc
Original Assignee
St Jude Medical Atrial Fibrillation Division Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St Jude Medical Atrial Fibrillation Division Inc filed Critical St Jude Medical Atrial Fibrillation Division Inc
Publication of EP1879637A2 publication Critical patent/EP1879637A2/fr
Publication of EP1879637A4 publication Critical patent/EP1879637A4/fr
Application granted granted Critical
Publication of EP1879637B1 publication Critical patent/EP1879637B1/fr
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers

Definitions

  • the present invention relates to bodies for catheters and sheaths and methods of manufacturing and using such bodies. More particularly, the present invention relates to splittable and radiopaque bodies and methods of manufacturing and using such bodies.
  • Catheters and sheaths are commonly manufactured with splittable (i.e., peelable or peel-away) type bodies that allow the catheter or sheath to be removed from about an implanted medical device (e.g., pacemaker leads) without disturbing the device.
  • Prior art bodies are formed with peeling grooves that extends longitudinally along the inner or outer circumferential surfaces of their walls in order to make the bodies splittable. Providing such peeling grooves is a difficult and expensive manufacturing process.
  • catheters and sheaths are commonly manufactured with tubular bodies having radiopaque distal tips. Such catheters and sheaths are used in cardiovascular procedures and other medical procedures.
  • the radiopaque distal tip may be viewed within a patient's body via an X-ray fluoroscope or other imaging system, thereby allowing a physician to position the tubular body as required during a procedure.
  • Prior art tubular bodies with radiopaque distal tips often use precious heavy metals (e.g., gold, platinum, tantalum) to achieve sufficient tip radiopacity.
  • precious heavy metals e.g., gold, platinum, tantalum
  • a thin band of a precious heavy metal is imbedded in the distal tip of each such prior art tubular body.
  • such prior art tubular bodies end up being quite expensive because of the high cost of the precious heavy metals and the labor intensive manufacturing processes used to manufacture such tubular bodies.
  • Tubular bodies are made from polymeric materials that may not be chemically compatible with the precious metal used to form the radiopaque distal band. As such, the distal band may not adhere to the material matrix of the tubular body, causing potential material separation and a discontinuity in mechanical strength.
  • EP 0010757A1 discloses a catheter comprising spirally disposed radiopaque stripes. The projection of the spirally disposed radiopaque stripes provides a line of intersection points in axial direction of the catheter. This document forms the preamble of claim 1.
  • the present invention is a body for a catheter or sheath.
  • the body comprises a lumen defined by a wall formed with longitudinal strips.
  • the first strip has a radiopacity that is higher than the second strip, providing the body with required visibility within a patient's body via an x-ray fluoroscope.
  • the body can have a tubular cross section as described in detail herein, or may have any other desirable cross section, e.g., generally triangular or square.
  • the present invention is a body for a catheter or sheath.
  • the body includes a proximal end, a distal end, a first longitudinal strip, and a second longitudinal strip.
  • the first and second strips extend between the proximal and distal ends.
  • the first strip can have a radiopacity that is higher than the second strip.
  • the first strip can be made of radiopaque polymeric compounds, including tungsten-filled polymer compounds.
  • the first and second strips may be helical along the body.
  • the first longitudinal strip may comprise between 2-50% of the circumference of the body.
  • the first longitudinal strip may comprise between 10-25% of the circumference of the body.
  • the first longitudinal strip may comprise between 1-5% of the circumference of the body.
  • the tubular body can include a proximal end, a distal end, a first longitudinal strip, and a second longitudinal strip.
  • the first and second longitudinal strips can be formed at the distal end of the tubular body only, and then bonded together to form the tubular body using various polymeric joining technologies.
  • the tubular body can have a cylindrical wall.
  • a wall cross-section of the cylindrical wall (as taken generally perpendicular to a longitudinal axis of the cylindrical wall) includes a first wall segment and a second wall segment. These two segments may form at least an integral portion of the wall cross-section, which may be circumferentially continuous and integral.
  • the first segment can have a radiopacity that is higher than the second segment.
  • the present invention includes a method of forming a tubular body for a catheter or sheath.
  • the tubular body includes a first longitudinal strip and a second longitudinal strip.
  • the method comprises providing a machine and relevant specialty tool, displacing a first material with the machine to create a first material stream, displacing a second material with the machine to create a second material stream, and bringing the first material stream into contact with the second material stream such that the first material stream forms the first longitudinal strip and the second material stream forms the second longitudinal strip.
  • the first and second strips may form at least a portion of a wall cross-section of the tubular body, wherein the wall cross-section is circumferentially continuous and integral.
  • the first material can have a radiopacity that exceeds the radiopacity of the second material.
  • the machine can be, for example, a co-extrusion machine, a co-injection molding machine, or a co-compression molding machine.
  • the tubular body can comprise a peel line formed by a longitudinally extending region of interfacial bonding between first and second longitudinally extending strips of polymer material.
  • the polymer materials of the first and second strips can differ in that the polymer material of the first strip is loaded with a greater amount of inorganic filler than the polymer material of the second strip.
  • the polymer material of the first strip can have a greater amount of radiopaque material than the polymer material of the second strip.
  • the radiopaque material can include a pure metal or metallic compound with at least one element with an atomic number from about 22 to about 83.
  • the polymer material of the first longitudinally extending strip can be functionally miscible with the polymer material of the second longitudinally extending strip.
  • the polymer material of the first longitudinally extending strip maybe comprised of at least one different polymer than the polymer material of the second longitudinally extending strip.
  • Each strip can form at least a portion of an outer circumferential surface of the tubular body.
  • a region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the splittable tubular body along the peel line.
  • the polymer material of the first strip can be dissimilar from, but chemically compatible with, the polymer material of the second strip.
  • the polymer material of the first strip may have a molecular orientation that is different from a molecular orientation of the polymer of the second strip.
  • the polymer material of the first strip can have a flow-induced axial molecular orientation.
  • the polymer material of the first strip can be chemically in-compatible with the polymer material of the second strip. If so, a polymer compatibilizer is introduced into at least one of the polymer materials to improve melt adhesion between the first and second strips of polymer material.
  • the splittable tubular body can include a first peel mechanism longitudinally extending along the body.
  • the first peel mechanism is formed by a longitudinally extending region of interfacial bonding between first and second longitudinally extending strips of polymer material.
  • FIG. 1 is an elevational view of the present invention, according to a first embodiment, including a splittable/peelable body for a catheter or sheath, wherein the body includes a distal end and a proximal end and is formed of at least two integral longitudinal strips of different material.
  • FIG. 2A is a latitudinal cross-sectional view of the first embodiment of the body taken through section line A-A in FIG. 1 .
  • FIG. 2B is a longitudinal cross-sectional view of the first embodiment of the tubular body taken through section line A'-A' in FIG. 2A .
  • FIG. 3 is an elevational view of the present invention according to a second embodiment including a splittable tubular body for a catheter or sheath, wherein the tubular body includes a distal end and a proximal end and is formed of at least two integral longitudinal strips of different material.
  • FIG. 4A is a latitudinal cross-sectional view of the second embodiment of the tubular body taken through section line B-B in FIG. 3 .
  • FIG. 4B is a longitudinal cross-sectional view of the second embodiment of the tubular body taken through section line B'-B' in FIG. 4A .
  • FIG. 4C is a latitudinal cross-sectional view of a first variation of the second embodiment of the tubular body taken through section line B-B in FIG. 3 .
  • FIG. 4D is a longitudinal cross-sectional view of the first variation of the second embodiment of the tubular body taken through section line B"-B" in FIG. 4C .
  • FIG. 4E is a latitudinal cross-sectional view of a second variation of the second embodiment of the tubular body taken through section line B-B in FIG. 3 .
  • FIG. 4F is a longitudinal cross-sectional view of the second variation of the second embodiment of the tubular body taken through section line B"'-B"' in FIG. 4E .
  • FIG. 5 is an elevational view of the present invention according to a third embodiment including a splittable tubular body for a catheter or sheath, wherein the tubular body includes a distal end and a proximal end and is formed of at least two integral longitudinal helical strips of different material.
  • FIG. 6A is a latitudinal cross-sectional view of the third embodiment of the tubular body taken through section line C-C in FIG. 5 .
  • FIG. 6B is a longitudinal cross-sectional view of the third embodiment of the tubular body taken through section line C'-C' in FIG. 6A .
  • FIG. 7 is an elevational view of the present invention according to a fourth embodiment including a splittable tubular body for a catheter or sheath, wherein the tubular body includes a distal end and a proximal end and is formed of at least two integral longitudinal helical strips of different material.
  • FIG. 8A is a cross-sectional view of the fourth embodiment of the tubular body taken through section line D-D in FIG. 7 .
  • FIG. 8B is a longitudinal cross-sectional view of the fourth embodiment of the tubular body taken through section line D'-D' in FIG. 8A .
  • FIG. 8C is a latitudinal cross-sectional view of a first variation of the fourth embodiment of the tubular body taken through section line D-D in FIG. 7 .
  • FIG. 8D is a longitudinal cross-sectional view of the first variation of the fourth embodiment of the tubular body taken through section line D"-D" in FIG. 8C .
  • FIG. 8E is a latitudinal cross-sectional view of a second variation of the fourth embodiment of the tubular body taken through section line D-D in FIG. 7 .
  • FIG. 8F is a longitudinal cross-sectional view of the second variation of the fourth embodiment of the tubular body taken through section line D"'-D"' in FIG. 8E .
  • FIG. 9 is similar to Fig. 2A , but is a cross-sectional view of the present invention according to a fifth embodiment, including a splittable tubular body, wherein the tubular body has integral peel grooves that can be located in either the first or the second longitudinal strips.
  • FIG. 10 is a cross-sectional view of a sixth embodiment of the splittable body, including a triangular cross-section.
  • FIG. 11 is a cross-section view of a seventh embodiment of the splittable body, including a square cross-section.
  • FIG. 1 is an elevational view of the present invention according to a first embodiment including a splittable (i.e., peel-away type) body 2 for a catheter or sheath.
  • the body 2 includes a distal end 4 and a proximal end 6.
  • the body 2 is formed of at least two integral longitudinal strips 8, 10 of different materials.
  • each strip 8, 10 may extend the full length of the tubular body 2 in a generally straight manner.
  • the body can have a tubular cross section.
  • the body can have a triangular 210 or square 220 cross-section.
  • the strips 8, 10 will be referred to herein as the first strip 8 and the second strip 10.
  • the material of the first strip 8 will be sufficiently different from the material of the second strip 10 so as to form a stress concentration along the interfacial zones (i.e., borders) 11 between the two strips 8, 10.
  • the stress concentration forms a peel line 11 that acts like a built-in peel groove.
  • the tubular body 2 is readily splittable although it lacks an actual peel groove.
  • the dissimilarity between the materials used to form the strips 8, 10 need only be sufficient enough to create a stress concentration that acts as a built-in peel groove. This may be accomplished in different ways, including the following ways.
  • the materials used for the strips 8, 10 may be generally the same, but can also differ.
  • the first strip 8 may be constructed from a first polymer and the second strip 10 may be constructed from a second polymer.
  • the polymer used for the first strip 8 may have a different molecular orientation than the polymer used for the second strip 10.
  • the material used for the first strip 8 is a polymer with flow-induced axial molecular orientation
  • the material used for the second strip 10 is a polymer having little or no flow-induced axial molecular orientation.
  • the tear strength along the flow-induced orientation direction for the polymeric material used for the first strip 8 will decrease due to the mechanical anisotropy induced by the molecular chain alignment.
  • the polymeric material used for the second strip 10 will have any one or all of the following attributes: high tear strength; high mechanical strength, high torquability; and high kink resistance.
  • materials that can be used for the first strip 8 and are easily molecularly oriented along the flow direction during polymer processing include, among other materials, crystal polymers like Ticona VectraTM, LKX 1107, and LKX 1113.
  • the base polymer materials used for the first and second strips 8, 10 can be chemically the same or similar, except, the material used for the first strip 8 can be loaded with semi-compatible or incompatible inorganic fillers.
  • Such fillers can include radiopaque fillers or other general-purpose fillers like silica, clay, graphite, mica, and calcium carbonate.
  • the tear strengths and the elongations at yield and break for the material used for the first strip 8 will decrease with the increase of the filler loading.
  • the base polymeric materials used for the first and second strips 8, 10 can be chemically in-compatible. If so, a polymer compatibilizer is introduced to at least one of the polymer materials used for the first and second strips 8, 10 to improve the melt adhesion between the first and second strips 8, 10.
  • the material used for the first strips 8 can be different from the material used for the second strip 10 with respect to molecular orientation and/or anisotropy in mechanical properties. This will especially be the case with respect to tear strength and elongation at yield and break. Furthermore, the materials used for the first and second strips 8, 10 will be at least partially compatible such that self-adhesion interfacial zones 11 are reliably formable between the strips 8, 10.
  • the materials used for the strips 8, 10 can be functionally miscible. To be functionally miscible, the two materials used for the strips 8, 10, must have sufficient adhesion to function for the intended use of the instrument, but must have sufficient stress concentrations formed at the interfacial zones 11 between the strips 8, 10 to readily act as a built-in peel groove when the instrument has completed its intended function. In another embodiment, the materials used for the strips 8, 10 are chemically miscible or partially miscible in order to impose the self-adhesion of the strips 8, 10 and create reliable interfacial regions 11 between said strips 8, 10.
  • the materials used for the strips 8, 10 include melt-processable thermoplastics (e.g., polyethylene, polyvinylidene fluoride, fluorinated ethylene-propylene copolymer, Polyethylene-co-tetrafluoroethylene, plypropylene, polyamide-6, polyamide-6.6, polyamide-11, polyamide-12, polyethylene terephathlate, polybutylenes terephathlate, polycarbonates, polystyrene, etc.) and thermoplastic elastomers (“TPEs”) (e.g., polyamide-based TPEs, olefinic TPEs, ionic TPEs, polyester-based TPEs, thermoplastic polyurethanes, etc.).
  • melt-processable thermoplastics e.g., polyethylene, polyvinylidene fluoride, fluorinated ethylene-propylene copolymer, Polyethylene-co-tetrafluoroethylene, plypropylene, polyamide-6, polyamide-6.6
  • the material used for the first strip 8 can be a material highly loaded with a radiopaque material.
  • the first strip 8 is referred to as the high radiopacity strip(s) 8.
  • the material used for the second strip 10 is a material that is not loaded or a material that is lightly loaded with a radiopaque material.
  • the second strip 10 is referred to as the low radiopacity strip(s) 10.
  • the tubular body 2 is inserted into the body of a patient via a surgical site (e.g., entering the chest cavity below the xiphoid process) and directed to a point of treatment (e.g., the pericardial space of a heart).
  • a surgical site e.g., entering the chest cavity below the xiphoid process
  • a point of treatment e.g., the pericardial space of a heart
  • the tubular body 2 is inserted into the body of a patient via a body lumen of a patient (e.g., a blood vessel) and manipulated so it travels along the body lumen to a point of treatment (e.g., a chamber in the heart).
  • a medical device is implanted at the point of treatment via the tubular body 2.
  • the tubular body 2 is longitudinally split along the interfaces 11 between the strips 8, 10 by simply forcing the sides of the tubular body 2 apart via a fingernail, tool or other implement.
  • the stress concentrations 11 formed at the interfaces 11 between the strips 8, 10 act as a built-in peel groove.
  • the split tubular body 2 is then removed from about the implanted medical device.
  • the tubular body 2 includes a first strip 8 formed from a material that is highly-loaded with a radiopaque material (i.e., the first strip 8 is a high radiopacity strip 8)
  • the travel and positioning of the tubular body 2 within the patient may be monitored via X-ray fluoroscopy.
  • the splittable tubular body 2 in its various embodiments provides the following advantages.
  • First, the tubular body 2 is readily splittable between the two types of strips 8, 10 without the presence of a peeling groove, score or skive.
  • Second, the tubular body 2 is less expensive to manufacture than prior art splittable tubular bodies because a peel groove does not need to be formed on the tubular body 2, and the tubular body 2 can be made in a single simple process, such as co-extrusion, co-injection molding, or co-compression molding.
  • tubular bodies 2 that have first strips 8 made of materials that are highly-loaded with radiopaque materials (i.e., tubular bodies 2 with high radiopacity strips 8), such tubular bodies 2 will also have the following advantages.
  • the tubular body 2 is made from compatible polymers or polymeric compounds without the use of pure metals or metallic compounds, the tubular body 2 has better material compatibility and mechanical integrity than prior art tubular bodies.
  • FIG. 2A is a cross-sectional view of the first embodiment of the tubular body 2 taken through section line A-A in FIG. 1 .
  • FIG. 2B is a longitudinal cross-sectional view of the first embodiment of the tubular body 2 taken through section line A'-A' in FIG. 2A .
  • the first embodiment of the tubular body 2 includes a wall 12 that has an outer circumferential surface 14 and an inner circumferential surface 16.
  • the outer circumferential surface 14 forms the outer surface of the tubular body 2 and the inner circumferential surface 16 defines a lumen 18 through the tubular body 2 that runs the full length of the tubular body 2.
  • each strip 8, 10 forms an integral segment of the wall 12.
  • the tubular body 2 in one embodiment, may have four first strips 8 and four second strips 10 that are formed together (e.g. under a co-extrusion process) to create a wall 12 that is circumferentially continuous and integral along its entire length.
  • one type of strip 8, 10 will outnumber the other type of strip 8, 10.
  • each strip 8, 10 will have a width that comprises approximately 25% of the circumference of the tubular body wall 12. In other embodiments where the strips 8, 10 each account for generally equal percentages of the circumference of the tubular body wall 12, the width of the strips 8, 10, depending on the total number of strips, will range between approximately 2% and approximately 50% of the circumference of the tubular body wall 12.
  • one type of strip 8, 10 may constitute a greater percentage of the circumference of the tubular body wall 12.
  • the first strips 8 may have greater widths than the second strips 10, or vice versa.
  • each of the four first strips 8 account for approximately 17% of the circumference of the tubular body wall 12, while each of the second strips 10 each account for approximately 8% of the circumference of the tubular body wall 12.
  • each of the two second strips 10 accounts for approximately 33% of the circumference of the tubular body wall 12, while each of the two first strips 8 accounts for approximately 17% of the circumference of the tubular body wall 12.
  • the width of the strips 8, 10 may range between approximately 2% and approximately 50% of the circumference of the tubular body wall 12. In other embodiments, the width of one or more of the strips 8, 10 will be between approximately 0.1 % and approximately 5% to form a micro strip 8, 10.
  • one or more of the strips 8, 10 may have a unique percentage of the circumference of the tubular body wall 12.
  • at least one (if not all) of the first strips 8 has a unique width.
  • the widths 8 of the first strips are not all equal.
  • a similar configuration could exist for at least one (if not all) of the second strips 10 or at least one (if not all) of the strips 8, 10.
  • the lumen 18 will have a diameter of between approximately 12 mm (4 French (“F")) and approximately 66 mm (22 F). In one embodiment, the tubular body 2 will have an outer diameter of between approximately 15 mm (5 F) and approximately 72 mm (24 F). In one embodiment the tubular body 2 will have a wall with a thickness of between approximately 0,15 mm (006") and approximately 0,66 mm (0.026").
  • FIG. 3 is an elevational view of a second embodiment of the radiopaque tubular body 2 having a distal end 4 and a proximal end 6 and being formed of at least two integral longitudinal strips 8, 10. These strips 8, 10 can have different radiopacities.
  • FIG. 4A is a latitudinal cross-sectional view of the second embodiment of the tubular body 2 taken through section line B-B in FIG. 3 .
  • FIG. 4B is a longitudinal cross-sectional view of the second embodiment of the tubular body 2 taken through section line B'-B' in FIG. 4A .
  • the second embodiment of the tubular body 2 and its strips 8, 10 are configured similarly to those in the first embodiment of the tubular body 2 as depicted in FIGS. 1, 2A and 2B , except the first strips 8 of the second embodiment are subjacent to layers of second strip material 10', 10" that form the outer and inner circumferential surfaces 14, 16 of the tubular body wall 12.
  • the first strips 8 of the second embodiment of the tubular body 2 are sandwiched between an outer layer 10' and an inner layer 10" of second strip material 10.
  • the first strips 8 of the second embodiment of the tubular body 2 are subjacent to a single layer of second strip material 10.
  • FIGS. 4C and 4D which are, respectively, a latitudinal cross-sectional view of the tubular body 2 taken through section line B-B in FIG. 3 and a longitudinal cross-sectional view of the tubular body 2 taken through section line B"-B" in FIG. 4C
  • the first strips 8 are subjacent to a single layer of second strip material 10, which is an outer layer 10'.
  • the second strip outer layer 10' forms the outer circumferential surfaces 14 of the tubular body wall 12 and the first strips 8 form segments of the inner circumferential surface 16 of the tubular body wall 12.
  • FIGS. 4E and 4F which are, respectively, a latitudinal cross-sectional view of the tubular body 2 taken through section line B-B in FIG. 3 and a longitudinal cross-sectional view of the tubular body 2 taken through section line B"'-B"' in FIG. 4E
  • the first strips 8 are subjacent to a single layer of second strip material 10, which is an inner layer 10".
  • the second strip inner layer 10" forms the inner circumferential surfaces 16 of the tubular body wall 12 and the first strips 8 form segments of the outer circumferential surface 14 of the tubular body wall 12.
  • FIG. 5 is an elevational view of a third embodiment of the tubular body 2 having a distal end 4 and a proximal end 6 and being formed of at least two integral longitudinal helical strips 8, 10. these strips 8, 10 can have different radiopacities.
  • FIG. 6A is a latitudinal cross-sectional view of the third embodiment of the tubular body 2 taken through section line C-C in FIG. 5 .
  • FIG. 6B is a longitudinal cross-sectional view of the third embodiment of the tubular body 2 taken through section line C'-C' in FIG. 6A .
  • the third embodiment of the tubular body 2 its strips 8, 10 are configured similarly to those in the first embodiment of the tubular body 2 as depicted in FIGS. 1, 2A and 2B , except the strips 8, 10 of the second embodiment extend spirally or helically along the length of the third embodiment of the tubular body 2.
  • FIG. 7 is an elevational view of a fourth embodiment of the tubular body 2 having a distal end 4 and a proximal end 6 and being formed of at least two integral longitudinal helical strips 8, 10. These strips 8, 10 can have different radiopacities.
  • FIG. 8 is a latitudinal cross-sectional view of the fourth embodiment of the tubular body 2 taken through section line D-D in FIG. 7 .
  • FIG. 8B is a longitudinal cross-sectional view of the fourth embodiment of the tubular body 2 taken through section line D'-D' in FIG. 8A .
  • the fourth embodiment of the tubular body 2 and its helical strips 8, 10 are configured similarly to those in the third embodiment of the tubular body 2 as depicted in FIGS. 5, 6A and 6B , except the helical first strips 8 of the fourth embodiment are subjacent to layers of second strip material 10', 10" that form the outer and inner circumferential surfaces of the tubular body wall 12.
  • the helical first strips 8 of the fourth embodiment of the tubular body 2 are sandwiched between an outer layer 10' and inner layer 10" of second strip material 10.
  • the first strips 8 of the fourth embodiment of the tubular body 2 are subjacent to a single layer of second strip material 10.
  • FIGS. 8C and 8D which are, respectively, a latitudinal cross-sectional view of the tubular body 2 taken through section line D-D in FIG. 7 and a longitudinal cross-sectional view of the tubular body 2 taken through section line D"-D" in FIG. 8C
  • the first strips 8 are subjacent to a single layer of second strip material 10, which is an inner layer 10".
  • the second strip inner layer 10" forms the inner circumferential surface 16 of the tubular body wall 12 and the first strips 8 form segments of the outer circumferential surface 14 of the tubular body wall 12.
  • FIGS. 8E and 8F which are, respectively, a latitudinal cross-sectional view of the tubular body 2 taken through section line D-D in FIG. 7 and a longitudinal cross-sectional view of the tubular body 2 taken through section line D"'-D"' in FIG. 8E
  • the first strips 8 are subjacent to a single layer of second strip material 10, which is an outer layer 10'.
  • the second strip outer layer 10' forms the outer circumferential surface 14 of the tubular body wall 12 and the first strips 8 form segments of the inner circumferential surface 16 of the tubular body wall 12.
  • the first strips 8 and the second strips 10 can be formed from two compatible polymers or polymeric compounds into an integral tubular body 2 via co-extrusion, co-injection molding, or co-compression molding processes.
  • suitable polymeric materials include thermoplastic and thermosetting polymer systems.
  • the first strips 8 may be formed of material that is heavily filled with a biocompatible filler of heavy metal or a biocompatible metallic compound that gives rise to high radiopacity under X-ray radiation.
  • the functional width and wall thickness (i.e., percentage of the circumference of the tubular body wall 12) necessary for visibility via X-ray fluoroscopy will vary depending on the degree of radiopacity for a first strip 8 (i.e., high radiopacity strip 8). For example, where a first strip 8 has a high degree of radiopacity (due to the radiopaque nature of the filler of metal or metallic compound impregnated in the polymer and/or due to the percentage of the metal or metallic compound in the polymer), narrower and thinner first strips 8 will suffice. On the other hand, where a first strip 8 has a lower degree of radiopacity, wider and thicker first strips 8 will be required to achieve the necessary visibility via X-ray fluoroscopy.
  • the first strips 8 (i.e., high radiopacity strips 8), if they are made from elastomeric polymer materials loaded with radiopaque fillers, provide kink resistance for the tubular body 2 in addition to providing the ability to be visualized within a patient's body via X-ray fluoroscopy.
  • the first strips 8 will be a tungsten-impregnated thermoplastic elastomer, including thermoplastic polyurethane, polyether block amide, and etc.
  • the amount of tungsten used will depend on the degree of radiopacity required and the thermoplastic elastomer. For example, when the strips are formed of PEBAX, the first strip can be loaded with 60-95% by weight tungsten, and preferably 80-85% by weight tungsten.
  • the second strips 10 are either not loaded with radiopaque fillers or are lightly loaded. Thus, the second strips 10 have a low radiopacity under X-ray radiation and provide mechanical strength and durability for the tubular body 2.
  • the selection of the pairs of polymers used for the strips 8, 10 is primarily based on the level of chemical compatibility, balance of mechanical properties, and melt processability between the pairs of polymers.
  • Different grades of polymers having the same constituent chemical species e.g., various thermoplastic elastomers, including polyether block amides, polyurethanes, olefinics, styrenics, polyesters, polyethers, and etc.
  • thermoplastics and thermoplastic elastomers can also be used (e.g., polyamides with polyether block amides, polyesters with polyether-co-esters).
  • Other polymer pairs are possible with use of polymer compatibilization technologies.
  • one base polymer from a polymer pair must be filled with heavy metals or metallic compounds using blending and compounding technologies via either melt or solvent processes.
  • the heavy metals and compounds shall be biocompatible (e.g., barium, tungsten, tantalum, platinum, gold, bismuth, zirconium, niobium, titanium, bismuth oxychloride, barium sulfate, bismuth trioxide, iodine, iodide, etc. and their compounds).
  • the biocompatible radiopaque filler will contain at least one element with an atomic number of from about 22 to about 83.
  • Filler of a heavy metal or a metallic compound may not be compatible with a selected base polymer, and may cause a drastic decrease in mechanical properties in the heavily loaded polymer compound.
  • a compatibilizer or coupling agent can be used for the polymer compound.
  • the tubular bodies 2 are peelable (i.e., splittable) at one or more border(s) (i.e., interface(s)) between the two types of strips 8, 10.
  • border(s) i.e., interface(s)
  • opposite sides of the interior circumferential surface 16 are simply forced apart via a fingernail, tool or other implement.
  • the change in material at the borders between the strips 8, 10 creates a stress concentration point that acts as a built in peel groove along which the tubular body 2 splits when peeled.
  • no integral peeling groove is needed.
  • an integral peel groove, skive or score 20 is provided to supplement the peelability of the tubular body 2. This can be readily implemented in the embodiments illustrated in FIGS. 1-4 .
  • this peel groove, skive or score 20 is aligned longitudinally with a boarder between a pair of strips 8, 10. However, the peel groove, skive or score 20 can be located in one of the strips 8, 10 as indicated in FIG. 9 .
  • a tubular body 2 can have one or more peel grooves, skives or scores. The peel groove, score or skive 20 can be located in the inner and/or outer circumferential surface of the tubular body 2.
  • the strips 8, 10 can be formed of polymers that are not loaded with a radiopaque or other materials.
  • the first strips 8 can be formed from a polymer that is dissimilar from the polymer forming the second strips 10. The dissimilarity between the two polymers forming the two strips 8, 10 results in a stress concentration along the interfacial boundary between the two strips 8, 10. The stress concentration serves as a split/peel feature in the tubular body 2 for splitting/peeling the body 2.
  • the polymers of the strips 8, 10 can be the same polymer, but dissimilar because they have dissimilar molecular orientations.
  • the polymers of the strips 8, 10 can be the same polymer, but dissimilar because they have different toughness, hardness, rigidity, and/or etc.
  • the first or splitting strip 8 can be formed of PEBAX having a durometer value of approximately 70D
  • the second or non-splitting strip 10 is formed of PEBAX having a durometer value of approximately 30-40D.
  • a puncture is made with a thin walled needle through the skin and into a blood vessel.
  • a guidewire is then placed through the needle into the blood vessel and the needle is withdrawn.
  • An intravascular introducer is advanced over the guidewire into the lumen of the blood vessel.
  • the tubular body 2 is inserted into the introducer and manipulated so it travels along the blood vessel to the point of treatment (e.g., a chamber in the heart). The travel and positioning of the tubular body 2 within the patient is monitored via X-ray fluoroscopy.
  • the tubular body 2 is inserted into the body of a patient via a surgical site (e.g., entering the chest cavity below the xiphoid process).
  • a guidewire is used to direct the tubular body 2 to a point of treatment (e.g., the pericardial space of a heart).
  • the travel and positioning of the tubular body 2 within the patient is monitored via X-ray fluoroscopy.

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  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)

Claims (32)

  1. Corps (2 ; 210 ; 220) pour un cathéter ou une gaine, le corps comprenant une partie proximale (6), une partie distale (4), un premier segment de paroi (8) et un deuxième segment de paroi (10), dans lequel les premier et deuxième segments de paroi s'étendent sous forme continue et intégrale généralement entre les parties proximale et distale, et dans lequel le premier segment de paroi a une radio-opacité qui est supérieure à celle du deuxième segment de paroi,
    caractérisé en ce que les segments de paroi s'étendent généralement entre les parties proximale et distale pour former au moins une partie d'une section transversale de la paroi qui soit séparable le long d'une région de concentration de contraintes s'étendant le long d'une démarcation interfaciale (11) située entre les premier et deuxième segments de paroi.
  2. Corps (2) selon la revendication 1, dans lequel le corps (2) présente une circonférence cylindrique.
  3. Corps selon la revendication 1 ou 2, dans lequel le corps (2) est tubulaire, le premier segment de paroi (8) comprend une première bande longitudinale (8), le deuxième segment de paroi (10) comprend une deuxième bande longitudinale (10) et la section transversale de la paroi est continue et intégrale au niveau de la circonférence.
  4. Corps (2) selon la revendication 2 ou 3, dans lequel la première bande longitudinale (8) ou le premier segment (8) constitue entre environ 2 % et environ 50 % de la circonférence du corps cylindrique ou tubulaire (2), mieux encore, entre environ 10 % et environ 25 % de la circonférence du corps cylindrique ou tubulaire.
  5. Corps (2) selon la revendication 2 ou 3, dans lequel la première bande longitudinale (8) ou le premier segment (8) constitue entre environ 1 % et environ 5 % de la circonférence du corps (2) cylindrique ou tubulaire.
  6. Corps (2) selon l'une quelconque des revendications précédentes, dans lequel la première bande longitudinale (8) ou le premier segment (8) est sous-jacent(e) à une première couche (10') et à une seconde couche (10") de la deuxième bande longitudinale (10), dans lequel la première couche forme une surface circonférentielle externe (14) du corps (2) et le seconde couche forme une surface circonférentielle interne (16) du corps.
  7. Corps (2) selon l'une quelconque des revendications précédentes, dans lequel les première et deuxième bandes longitudinales (8, 10) sont disposées sous forme hélicoïdale le long du corps (2).
  8. Corps (2) selon l'une quelconque des revendications précédentes, dans lequel la première bande longitudinale (8) ou le premier segment (8) est formé(e) à partir d'un premier polymère, le premier polymère comprenant au moins un polymère et une charge radio-opaque biocompatible de métal pur ou d'un composé métallique ayant au moins un élément ayant un numéro atomique d'environ 22 à environ 83, de préférence le tungstène.
  9. Corps (2) selon l'une quelconque des revendications précédentes, comprenant en outre une troisième bande longitudinale (8) et une quatrième bande longitudinale (10), dans lequel la troisième bande longitudinale comprend un matériau polymère, le matériau polymère comprenant une charge radio-opaque, et la troisième bande et la quatrième bande présentent chacune une radio-opacité, la radio-opacité de la troisième bande étant supérieure à la radio-opacité de la quatrième bande.
  10. Corps (2) selon la revendication 9, comprenant en outre une cinquième bande longitudinale (8) et une sixième bande longitudinale (10), dans lequel la cinquième bande longitudinale comprend un matériau polymère, le matériau polymère comprenant une charge radio-opaque, et la cinquième bande et la sixième bande présentent chacune une radio-opacité, la radio-opacité de la cinquième bande étant supérieure à la radio-opacité de la sixième bande.
  11. Corps (2) selon l'une quelconque des revendications 3 à 8, dans lequel la section transversale (12) de la paroi comprend en outre un troisième segment (8) et un quatrième segment (10), dans lequel les troisième et quatrième segments forment au moins une partie de la section transversale de la paroi, et le troisième segment et le quatrième segment présentent chacun une radio-opacité, la radio-opacité du troisième segment étant supérieure à la radio-opacité du quatrième segment.
  12. Corps (2) selon la revendication 11, dans lequel la section transversale (12) de la paroi comprend en outre un cinquième segment (8) et un sixième segment (10), dans lequel les cinquième et sixième segments forment au moins une partie de la section transversale de la paroi, et le cinquième segment et le sixième segment présentent chacun une radio-opacité, la radio-opacité du cinquième segment étant supérieure à la radio-opacité du sixième segment.
  13. Procédé pour former un corps tubulaire (2) d'un cathéter ou d'une gaine, le corps tubulaire comprenant une première bande longitudinale (8) d'un matériau polymère et une deuxième bande longitudinale (10) d'un matériau polymère, le procédé comprenant les étapes consistant à :
    mettre en oeuvre une machine ;
    déplacer un premier matériau polymère avec la machine de manière à créer un courant de premier matériau ;
    déplacer un second matériau polymère avec la machine de manière à créer un courant de second matériau ; et
    amener le courant de premier matériau en contact avec le courant de second matériau, de sorte que le courant de premier matériau forme la première bande longitudinale et le courant de second matériau forme la deuxième bande longitudinale, dans lequel les première et deuxième bandes forment au moins une partie d'une section transversale (12) de la paroi du corps tubulaire, et dans lequel la section transversale de la paroi est circonférentielle, de manière continue et intégrale, tout en étant séparable le long d'une région de concentration de contraintes s'étendant le long d'une zone interfaciale située entre les première et deuxième bandes.
  14. Procédé selon la revendication 13, dans lequel le premier matériau polymère a une première radio-opacité et le second matériau polymère a une seconde radio-opacité, et dans lequel la première radio-opacité est supérieure à la seconde radio-opacité.
  15. Procédé selon la revendication 13 ou 14, dans lequel le premier matériau polymère est différent du second matériau polymère, mais chimiquement compatible avec celui-ci.
  16. Procédé selon la revendication 13 ou 14, dans lequel le premier matériau polymère n'est pas chimiquement compatible avec le second matériau polymère et un agent de compatibilisation de polymères est introduit dans au moins l'un des matériaux polymères, afin de renforcer l'adhérence à l'état fondu entre les première et deuxième bandes (8, 10) de matériau polymère.
  17. Procédé selon l'une quelconque des revendications 13 à 16, dans lequel le premier matériau polymère présente une orientation moléculaire qui est différente d'une orientation moléculaire du second matériau polymère.
  18. Procédé selon l'une quelconques des revendications 13 à 17, dans lequel le premier matériau polymère présente une orientation moléculaire axiale induite par flux.
  19. Procédé selon l'une quelconque des revendications 13 à 18, dans lequel le premier matériau polymère est chargé d'une quantité supérieure de charge inorganique en comparaison du second matériau polymère.
  20. Procédé selon l'une quelconque des revendications 13 à 19, dans lequel la machine est une machine de coextrusion, une machine de moulage par co-injection ou une machine de moulage par co-compression.
  21. Corps (2) selon l'une quelconque des revendications 1 à 3, dans lequel un matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) est miscible au plan fonctionnel avec un matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10).
  22. Corps (2) selon la revendication 21, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) est constitué d'au moins un matériau polymère différent du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10).
  23. Corps (2) selon la revendication 21 ou 22, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) est chargé par une quantité de charge inorganique plus élevée en comparaison du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10).
  24. Corps (2) selon l'une quelconque des revendications 21 à 23, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) est chargé par une quantité supérieure de matériau radio-opaque en comparaison du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du second segment de paroi (10), la deuxième bande s'étendant longitudinalement ou le deuxième segment de paroi ne comprenant éventuellement pas de matériau radio-opaque.
  25. Corps (2) selon l'une quelconque des revendications 21 à 24, dans lequel chaque bande (8, 10) s'étendant longitudinalement ou segment de paroi (8, 10) forme au moins une partie d'une surface circonférentielle externe (14) du corps tubulaire.
  26. Corps (2) selon l'une quelconque des revendications 21 à 25, dans lequel une région de concentration de contraintes s'étend le long de la démarcation interfaciale (11) entre les première et deuxième bandelettes (8, 10) s'étendant longitudinalement ou les segments de paroi (8, 10).
  27. Corps (2) selon la revendication 26, dans lequel la région de concentration de contraintes est adaptée pour faciliter la séparation du corps tubulaire séparable le long de la démarcation interfaciale (11).
  28. Corps (2) selon l'une quelconque des revendications 21 à 27, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) est différent du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10), mais chimiquement compatible avec celui-ci.
  29. Corps (2) selon l'une quelconque des revendications 21 à 28, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) présente une orientation moléculaire qui est différente de l'orientation moléculaire du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10).
  30. Corps (2) selon la revendication 29, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) présente une orientation moléculaire axiale induite par flux.
  31. Corps (2) selon l'une quelconque des revendications 21 à 27, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) n'est pas chimiquement compatible avec le matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10), et un agent de compatibilisation de polymères est introduit dans au moins l'un des matériaux polymères afin de renforcer l'adhérence à l'état fondu entre les première et deuxième bandes s'étendant longitudinalement ou les segments de paroi de matériau polymère.
  32. Corps (2) selon l'une quelconque des revendications 21 à 31, dans lequel le matériau polymère de la première bande (8) s'étendant longitudinalement ou du premier segment de paroi (8) présente une dureté, une rigidité et/ou une ténacité différente(s) en comparaison du matériau polymère de la deuxième bande (10) s'étendant longitudinalement ou du deuxième segment de paroi (10).
EP20060751861 2005-04-28 2006-04-28 Corps pour catheter ou gaine Ceased EP1879637B1 (fr)

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US67597305P 2005-04-28 2005-04-28
PCT/US2006/016373 WO2006116720A2 (fr) 2005-04-28 2006-04-28 Corps pour catheter ou gaine

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EP1879637A4 EP1879637A4 (fr) 2009-11-18
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WO2006116720A3 (fr) 2007-05-10
CA2604715A1 (fr) 2006-11-02
CN101166556A (zh) 2008-04-23
EP1879637A2 (fr) 2008-01-23
US10076639B2 (en) 2018-09-18
WO2006116720A2 (fr) 2006-11-02
US9126019B2 (en) 2015-09-08
US20080154206A1 (en) 2008-06-26
CN101166552A (zh) 2008-04-23
AU2006239223A1 (en) 2006-11-02
CN101166552B (zh) 2014-12-10
AU2006239223B2 (en) 2010-08-05
BRPI0609069A2 (pt) 2010-02-17
IL186587A0 (en) 2008-01-20
EP1879637A4 (fr) 2009-11-18
JP2008539049A (ja) 2008-11-13
ATE516843T1 (de) 2011-08-15
US20160008583A1 (en) 2016-01-14
IL186587A (en) 2014-11-30
CN101166556B (zh) 2011-03-30
CA2604715C (fr) 2011-08-30

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